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European Commission grants Macugen regulatory approval
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The European Commission has granted Macugen regulatory approval, according to a press release from OSI Pharmaceuticals.
The company announced that its development and marketing partner, Pfizer Inc., was approved to market Macugen (pegaptanib sodium injection) in Europe for the treatment of neovascular age-related macular degeneration.
“We are pleased that our partner Pfizer will make this important medicine available to patients in Europe,” David Guyer, MD, OSI Pharmaceuticals executive vice president, said in the release.
Regulatory approval was based on the results of two clinical trials involving 1,186 patients with all subtypes of neovascular AMD.
Results showed that 70% of patients receiving 0.3 mg of Macugen every 6 weeks lost fewer than three lines of vision on the eye chart by week 54 compared with 55% of the control group, meeting the primary efficacy endpoint of the trials.
Two-year clinical data from the trials also showed Macugen to be well tolerated, with a continued treatment benefit.
“In rigorous clinical studies, Macugen was effective and well-tolerated over 2 years, an important consideration for older patients treated for this chronic, progressive disease,” Dr. Guyer said.
According to the press release, 2.5 million people in the European Union have some form of neovascular AMD. This approval will make Macugen the first therapy approved in Europe for the treatment of all types of neovascular AMD, regardless of lesion subtype, size or baseline visual acuity.
OSI said in the release that the safety and efficacy of Macugen have not been demonstrated beyond 2 years and that European prescribing information would include post-marketing cases of an allergic reaction that occurred in some patients within several hours after injection. No direct relationship has been established between Macugen and these allergic reactions, according to OSI.
OSI and Pfizer co-promote Macugen in the United States, but OSI has granted Pfizer the exclusive rights to market Macugen in countries outside the United States.